Recruiting

Transcutaneous Spinal Cord Stimulation

Sponsor:

UCLA

Code:

NCT05265000

Conditions

Chronic Low-back Pain

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

tSpinalStim

Study Details

Brief summary:

As a leading cause of disability worldwide, chronic low back pain (cLBP) represents a significant medical and socioeconomic problem with estimated health care spending of $87 billion/annually. The efficacy of dorsal column electrical stimulation to inhibit pain was first described over 50 years ago. Since then, several large clinical trials have investigated the therapeutic potential of electrical spinal cord stimulation (SCS) and found that over 70% of patients with intractable pain had over 50% pain relief after 1 year of treatment. Thus, SCS is a promising therapeutic intervention that has superior patient outcomes when compared to traditional modalities for the treatment of cLBP. To date, SCS for treatment of cLBP has been delivered via epidural electrodes, requiring neurosurgical implantation. Although, the implantable stimulators have a low rate of adverse events, secondary complications associated with surgical intervention still occur.Transcutaneous spinal cord stimulation (tSCS) is a rapidly developing non invasive neuromodulation technique in the field of spinal cord injury. Its application potentiates lumbosacral spinal cord excitability enabling motor functions, (e.g. independent standing, postural control) in patients with chronic complete motor paralysis. Given that epidural and transcutaneous SCS activate similar neuronal networks, tSCS for cLBP treatment may be advantageous due to its non-invasive nature which may also allow for a mass market production and rapid patient availability if tSCS is proven efficacious. In this pilot study we will establish the feasibility of tSCS to acutely improve patient reported outcomes (pain scores) and several objective measures, including sit-to-stand biomechanics, neurophysiological and neuroimaging outcomes.

Conditions

Chronic Low-back Pain

Study ID

NCT05265000

Start date

Aug 1, 2022

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Low back pain
  • Able to get in and out of chair unassisted
  • No changes in medication within 2 weeks of study enrollment
  • Stable dose of their medications within 2 weeks of study enrollment

Exclusion Criteria:

  • Body Mass Index (BMI) > 28
  • Hardware in the spine from prior surgeries
  • Presence of epidural stimulation leads
  • Presence of any additional neuromuscular pain unrelated to spinal condition
  • Intolerance to any form of electrical stimulation, such as neuromuscular stimulation in the past
  • Lack of perceived endurance to go through multiple experimental assessments in one day/complete the study which may take up to 3 hours
  • Changes in medications within 2 weeks of study enrollment
  • Moderate/severe depression (Beck Depression Inventory score > 20)

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: tSpinalStim

Individuals in this arm will receive spinal cord stimulation

Interventions

tSpinalStim

Patients will undergo 12-21 sessions of spinal cord stimulation therapy (30 minutes per session, 3 times a week). Up to five round stimulating electrodes will be placed on the skin midline between spinous processes in cervical, thoracic and/or lumbar region, as cathodes and rectangular pads will be placed symmetrically on the skin over the iliac crests as anodes. The stimulator generates pain-free biphasic rectangular waveform with 1 ms width pulses filled with 5-10 kHz (kilohertz) carrier frequency. A range of stimulation intensities from 0-250 mA (milliamps) may be used. We expect that the stimulation intensities needed for therapeutic effect may differ based on individual's body mass index and/or the amount of subcutaneous fat present at the stimulation site.

Primary outcome measure

  • Visual Analogue Scale (VAS) score [ Time Frame: 3 hours ]
  • Max Sagittal Vertical Axis [ Time Frame: 3 hours ]
  • L5S1/Torso Max Flex/Ext angle [ Time Frame: 3 hours ]
  • L5S1/Torso Max velocity [ Time Frame: 3 hours ]
  • Hip/Pelvis Max Flex/Ext angle [ Time Frame: 3 hours ]
  • Hip/Pelvis Max velocity [ Time Frame: 3 hours ]
  • Thing/Knee Max Flex/Ext angle [ Time Frame: 3 hours ]
  • Thing/Knee Max Velocity [ Time Frame: 3 hours ]
  • Insula - Cingulate connectivity [ Time Frame: 3 hours ]
  • Default Mode Network connectivity [ Time Frame: 3 hours ]
  • Erector Spinae activation (Root Mean Square) [ Time Frame: 3 hours ]
  • Rectus Femoris activation (Root Mean Square) [ Time Frame: 3 hours ]

Central Contacts and Locations

Central contacts

Locations

San Francisco VA Medical Center

Recruiting

San Francisco, California, United States, 94121

Contacts

Anastasia Keller, PhD

anastasia.keller@ucsf.edu

Principal Investigator:

Anastasia V Keller, PhD

More Information

Sponsor

University of California, San Francisco

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

  • non-invasive, spinal cord stimulation, neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-03-06.